Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Siemens Healthcare Diagnostics Inc.
10732871
In Commercial Distribution

  • 00630414208275 ()
CWT-80001

  • Medical equipment clinical data interfacing software
Free T3 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10310318
In Commercial Distribution

  • 00630414207537 ()
  • 00630414003337 ()
119781

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Free T3 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310317
In Commercial Distribution

  • 00630414207520 ()
119780

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Digitoxin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10329308
Not in Commercial Distribution

  • 00630414207414 ()
  • 00630414003658 ()
119714

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® BR (5-pack)
Siemens Healthcare Diagnostics Inc.
10340081
In Commercial Distribution

  • 00630414204772 ()
  • 00630414010663 ()
118803

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® VB12 (5-pack)
Siemens Healthcare Diagnostics Inc.
10336453
In Commercial Distribution

  • 00630414204758 ()
  • 00630414010656 ()
118806

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Carcino-Embryonic Antigen (Ref) - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10333162
In Commercial Distribution

  • 00630414204741 ()
  • 00630414010632 ()
118808

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® FSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337964
In Commercial Distribution

  • 00630414204666 ()
  • 00630414010601 ()
118821

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Progesterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310305
In Commercial Distribution

  • 00630414204147 ()
118530

  • Progesterone IVD, kit, chemiluminescent immunoassay
Digitoxin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310301
Not in Commercial Distribution

  • 00630414203935 ()
118453

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Prostate-specific Antigen (PSA) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10310292
In Commercial Distribution

  • 00630414203003 ()
118156

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Calibrator Q - 2 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310295
In Commercial Distribution

  • 00630414202938 ()
118220

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator Q - 6 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310296
In Commercial Distribution

  • 00630414202921 ()
118221

  • Total prostate specific antigen (tPSA) IVD, calibrator
Luer Capillary (pack of 2) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
Siemens Healthcare Diagnostics Inc.
10323407
In Commercial Distribution

  • 00630414299181 ()
  • 00630414202433 ()
106050

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers.
Siemens Healthcare Diagnostics Inc.
10309926
In Commercial Distribution

  • 00630414202174 ()
  • 00630414009209 ()
108868

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers.
Siemens Healthcare Diagnostics Inc.
10309927
In Commercial Distribution

  • 00630414202167 ()
  • 00630414009216 ()
108869

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers.
Siemens Healthcare Diagnostics Inc.
10309925
In Commercial Distribution

  • 00630414202150 ()
  • 00630414009193 ()
108860

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Rubella IgM - CENTAUR - CONS - 2x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310286
In Commercial Distribution

  • 00630414201443 ()
117734

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
Rubella IgM Ab - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310285
In Commercial Distribution

  • 00630414201436 ()
117733

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
BNP - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309047
In Commercial Distribution

  • 00630414472836 ()
2817266

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
BNP - CENTAUR - CONS - 3x3x2mL
Siemens Healthcare Diagnostics Inc.
10309046
In Commercial Distribution

  • 00630414472829 ()
2817045

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Homocysteine Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310377
In Commercial Distribution

  • 00630414468235 ()
124583

  • Homocysteine IVD, control
Homocysteine Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10318677
In Commercial Distribution

  • 00630414468211 ()
  • 00630414003535 ()
124581

  • Buffered sample diluent IVD
Homocysteine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10310376
In Commercial Distribution

  • 00630414468198 ()
124579

  • Homocysteine IVD, calibrator
Homocystein - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10310375
In Commercial Distribution

  • 00630414468181 ()
124578

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Homocystein - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310374
In Commercial Distribution

  • 00630414468174 ()
124577

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10316526
In Commercial Distribution

  • 00630414468143 ()
  • 00630414009445 ()
2144067

  • Lactate electrode IVD
Two stage gas Pressure Regulator for Siemens Healthcare Diagnostics Blood Gas Systems
Siemens Healthcare Diagnostics Inc.
10310422
In Commercial Distribution

  • 00630414467818 ()
127191

  • Multiple blood gas analyte IVD, calibrator
Insulin Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10310463
In Commercial Distribution

  • 00630414466200 ()
129885

  • Buffered sample diluent IVD
Insulin Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310462
In Commercial Distribution

  • 00630414466187 ()
  • 00630414003375 ()
129883

  • Buffered sample diluent IVD
For in vitro diagnostic use for multi-level quality control of RAPIDPoint 400/500 series and RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10310323
In Commercial Distribution

  • 00630414465883 ()
120241

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CA 125 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10315696
In Commercial Distribution

  • 00630414461304 ()
  • 00630414003504 ()
128533

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 125 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310443
In Commercial Distribution

  • 00630414461298 ()
128532

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA15-3 master curve material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10330854
In Commercial Distribution

  • 00630414461281 ()
128531

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA 125 II Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310442
In Commercial Distribution

  • 00630414461274 ()
128530

  • Cancer antigen 125 (CA125) IVD, control
Insulin - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310439
In Commercial Distribution

  • 00630414461021 ()
128434

  • Insulin IVD, kit, chemiluminescent immunoassay
Insulin - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10310438
In Commercial Distribution

  • 00630414461014 ()
128433

  • Insulin IVD, calibrator
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